Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT01456156
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2011-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-02', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 year', 'description': 'the rate of overall survival for 3 year'}], 'secondaryOutcomes': [{'measure': 'local recurrence free survival', 'timeFrame': '3 years', 'description': 'the rate of local recurrence free survival for 3 years'}, {'measure': 'disease free survival', 'timeFrame': '3 years', 'description': 'the rate of disease free survival for 3 years'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'postoperative radiotherapy'], 'conditions': ['Hepatocellular Cancer']}, 'referencesModule': {'references': [{'pmid': '34097307', 'type': 'DERIVED', 'citation': 'Chen B, Wu JX, Cheng SH, Wang LM, Rong WQ, Wu F, Wang SL, Jin J, Liu YP, Song YW, Ren H, Fang H, Tang Y, Li N, Li YX, Wang WH. Phase 2 Study of Adjuvant Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC. Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.', 'detailedDescription': 'Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent provided\n* 18\\~75 years old\n* patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence\n* without any lymph node or distant metastasis (any T N0M0)\n* liver function: Child-Pugh A or B\n* Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1\n* life expectation\\>6 months\n* no dysfunction of major organs\n* no prior radiotherapy\n* negative for human immunodeficiency virus syndrome (HIV)\n* Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT\n\nExclusion Criteria:\n\n* malignant tumors of other sits\n* combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection\n* surgery performed in other hospitals without details\n* pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)'}, 'identificationModule': {'nctId': 'NCT01456156', 'briefTitle': 'Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study', 'orgStudyIdInfo': {'id': 'CH-GI-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hepatectomy plus radiotherapy', 'interventionNames': ['Radiation: postoperative radiotherapy']}], 'interventions': [{'name': 'postoperative radiotherapy', 'type': 'RADIATION', 'otherNames': ['adjuvant radiotherapy'], 'description': 'IMRT or 3DCRT, 50-60Gy to the tumor bed', 'armGroupLabels': ['hepatectomy plus radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tao Zhang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}